Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

Conditions

• Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Alirocumab — DRUG
  Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
• Rosuvastatin — DRUG
  Rosuvastatin over-encapsulated tablets orally.
• Ezetimibe — DRUG
  Ezetimibe over-encapsulated tablets orally.
• Placebo — DRUG
  Placebo for alirocumab and ezetimibe.

Study Details

To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.

Key Dates

Start date

Nov 30, 2012

Status verified

Mar 2020

Primary completion

Apr 30, 2014

Completion

May 31, 2014

Study Design

Enrollment

305 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Rosuvastatin 20 mg
  Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
• Active Comparator: Ezetimibe 10 mg + Rosuvastatin 10 mg
  Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
• Experimental: Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg
  Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
• Active Comparator: Rosuvastatin 40 mg
  Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
• Active Comparator: Ezetimibe 10 mg + Rosuvastatin 20 mg
  Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
• Experimental: Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg
  Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis [ Time Frame: From Baseline to Week 24 ]

Locations (54)

Find similar trials in Chandler, AZ

Related Studies

• Causes and Natural History of Dyslipidemias
  Recruiting · National Heart, Lung, and Blood Institute (NHLBI) · Bethesda, Maryland
• Alirocumab in Patients on a Stable Dialysis Regimen
  PHASE3 · Recruiting · Baylor Research Institute · Dallas, Texas
• Pharmacogenomic Informed Statin Prescribing
  Recruiting · VA Office of Research and Development · Indianapolis, Indiana
• Vascular Intervention Strategies Trial for Alzheimer's
  PHASE2 · Not Yet Recruiting · University of Southern California · Los Angeles, California